MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE 1.5T SIGNA HDX MR SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Multiple Fractures (4519)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

There are no additional device identification numbers.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported by a customer that a patient sustained fractures of multiple ribs following a mr breast examination.The injury consisted of fractures of the right anterior lateral 4th, 5th, 7th and 8th ribs and at the chondro-cartilage junction of the 4th, 5th, 6th, 7th and 8th ribs with a subacute element of interval healing.The customer denies any traumatic incident that occurred during the mr examination.

Manufacturer Narrative

B4; g1, 3, 6; h2, 3, 6.H3: the investigation by ge healthcare has been completed.Based on information available, the mr scanner appeared to be functioning according to specification.The technologist positioned the patient on the coil correctly, adding an additional small pad for the patientâs comfort.The patient's body weight in contact with the breast coil for the length of the examination in addition to a potential underlying or pre-existing medical conditions may have contributed to the injury.The investigation did not identify any issues with the device.

• Brand Name: GE 1.5T SIGNA HDX MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 11406607
• MDR Text Key: 234530882
• Report Number: 2183553-2021-00004
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K052293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 88